NCT00510419CompletedPhase 3
A Phase 3 Open-Label Study to Assess Subcutaneous Self-Injection With Sumatriptan Succinate Using an Auto-injector During a Single Migraine Attack
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 73
- Locations
- 20
- Primary Endpoint
- Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
Study Overview
Brief Summary
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.
Detailed Description
Investigational Plan:
- Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]
- Baseline Visit [Visit 1 / Provision of study drug and subject training]
- Treatment Visit [Visit 2 / within 72 hours after study drug administration]
- Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 18 to 60 years of age
- •Prior effective use of injectable sumatriptan on at least two occasions within the last two months
- •At least two migraines per month suitable injectable sumatriptan
- •Capable of using a migraine self-injection auto-injector
- •Capable of distinguishing between migraine and other headache types (e.g., tension-type headache)
Exclusion Criteria
- •Seizure disorders
- •Coronary artery disease (CAD)
- •Cardiac dysrhythmia or pacemaker
- •High blood pressure
- •Liver disease
- •Kidney disease
- •Autoimmune disease
- •History of alcohol or substance abuse
- •Currently pregnant
- •Use of any other investigational drug product within 30 days prior to treatment visit
Outcomes
Primary Outcomes
Successful administration and acceptability of self-injection of sumatriptan under the skin using an investigational auto-injector will be assessed by use of patient-completed scales and a short questionnaire.
Secondary Outcomes
- • Comparison of pain scores pre-dose and 2 hours post-dose. • Preference of investigational auto-injector experience compared to subject's previous self-administration of sumatriptan.
Investigators
Study Sites (20)
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